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Shark Screw® - Hand- and Foot Surgery Study

NCT ID: NCT04109469

Last Updated: 2019-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-27

Study Completion Date

2019-02-07

Brief Summary

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This observational study aims to determine the efficacy and safety of the Shark Screw® transplant for osteotomy and arthrodesis in hand and foot surgery.

Detailed Description

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The Shark Screw® transplant (surgebright GmbH) is a human cortical bone allograft for osteosynthesis and can replace metal or bioabsorbable devices in various procedures. In total, the clinical records from 32 patients who had undergone surgical procedure at the hand or foot between October 2016 and January 2018 with the use of a Shark Screw® transplant for joint arthrodesis or for the stabilization of osteotomies serve as data sources for this study. The aim of this study is to evaluate the efficacy and safety of the Shark Screw® transplant in hand and foot surgery by analyzing the recovery, wound and bone healing process.

Conditions

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Arthrodesis Osteotomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Shark Screw® transplant

Application of a Shark Screw® transplant for osteosynthesis or arthrodesis in hand- or foot surgery

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Application of the human bone graft Shark Screw® in a Hand- or Foot surgical procedure between October 2016 and January 2018
* Data from at least 1 follow-up examination after surgery around the 6th post-operative week or other information about the health status of the patient in the first 6 post-operative weeks

Exclusion Criteria

* not enough data for an objective analysis
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Surgebright Gmbh

INDUSTRY

Sponsor Role collaborator

Klinik Diakonissen Linz GmbH

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Klaus Pastl, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Klinik Diakonissen Linz

Locations

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Klinik Diakonissen Linz GmbH

Linz, , Austria

Site Status

Countries

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Austria

Other Identifiers

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1099/2018

Identifier Type: -

Identifier Source: org_study_id